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Analysts called the approval a much-needed win for Novo Nordisk, but warned that the company could struggle to grow sales once rival drugs come to market.
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The second half finished strong after two tumultuous years. What will 2026 bring for the biotech sector?
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
After 27 years in business, Cytokinetics hopes to pit its own cardiac myosin inhibitor against one it initially developed—now owned by Bristol Myers Squibb—in a market worth billions. Aficamten has a PDUFA date of Dec. 26.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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The over-representation of males and Hispanic patients in Eli Lilly’s Phase III ATTAIN-1 study could explain why orforglipron “underperformed” expectations in a previous readout, according to analysts at BMO Capital Markets.
OLN324 targets both VEGF and Ang2, the same mechanism of action as Roche’s Vabysmo, the Swiss giant’s multi-blockbuster treatment for wet macular degeneration and diabetic macular edema.
Transparency doesn’t drive people away. It attracts the right ones and keeps them committed. Leadership coach Angela Justice discusses the problem with leaders only selling the upside and the value of setting accurate expectations from the start.
The world of healthcare is evolving to more predictive care and patients are taking greater control—a trend already emerging around GLP-1 weight loss treatments. As PwC warns, pharma will need to be ready.
From a small team of researchers and skipped salaries, CEO Michelle Xia has steered Akeso to become one of the most exciting companies in the industry today.
While the FDA is trumpeting this new initiative as “sweeping reforms” to the way drug companies can advertise, experts say the regulator is going after a problem that doesn’t exist.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
A new analyst survey suggests that doctors are still prescribing Sarepta’s Elevidys, even after a series of deaths in certain populations marred the gene therapy’s record.
The sub-analysis, presented at the European Association for the Study of Diabetes congress, showed improved safety data to counteract past tolerability issues.
Both Novo Nordisk and Eli Lilly are eyeing regulatory advancements for their obesity blockbusters as the European Association for the Study of Diabetes’ annual conference continues this week.